US20020111587A1 - Injection device for injecting fluid - Google Patents
Injection device for injecting fluid Download PDFInfo
- Publication number
- US20020111587A1 US20020111587A1 US09/784,661 US78466101A US2002111587A1 US 20020111587 A1 US20020111587 A1 US 20020111587A1 US 78466101 A US78466101 A US 78466101A US 2002111587 A1 US2002111587 A1 US 2002111587A1
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- United States
- Prior art keywords
- injection device
- counter component
- bushing
- driven member
- actuator
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31545—Setting modes for dosing
- A61M5/31548—Mechanically operated dose setting member
- A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
- A61M5/31553—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31501—Means for blocking or restricting the movement of the rod or piston
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
- A61M2005/14573—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for quick connection/disconnection with a driving system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2403—Ampoule inserted into the ampoule holder
- A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2485—Ampoule holder connected to rest of syringe
- A61M2005/2488—Ampoule holder connected to rest of syringe via rotation, e.g. threads or bayonet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31525—Dosing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31545—Setting modes for dosing
- A61M5/31548—Mechanically operated dose setting member
- A61M5/31563—Mechanically operated dose setting member interacting with a displaceable stop member
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
- A61M5/3158—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button
Definitions
- the present invention relates to an injection device for injecting fluid from a fluid container. It also relates to an actuator for such an injection device.
- Syringe-shaped injection devices for injecting fluids have been known for some time. They contain a bushing-shaped main body which can be screwed together at approximately the centre and can be divided into two main sections:
- a distal section (facing away from the patient) containing the discharge mechanism and comprising at least one rod-shaped driven member having a structured surface (e.g. a screw rod), a hollow cylindrical counter component corresponding to the driven member, provided with a structured internal sleeve (e.g. a screw nut); and
- a proximal section (facing the patient) containing the fluid to be administered and a movable piston.
- a needle and a needle holder are attached, allowing the fluid to be discharged from the device; known needles of this type are for instance needles as described in WO95/01812.
- the connecting member between the proximal and the distal section of the main body is the driven member, shifting the piston by the required dose in proximal direction and discharging the fluid through the needle.
- the fluid to be injected is not directly contained in the main body but in an ampoule or container, with the fluid being stored between a piercable membrane and a piston displaceable by sliding.
- the threaded nut is spread due to the release of the distal section from the proximal section of the main body, allowing the threaded rod to move freely without any conscious operation by the patient, with screwing together of both sections of the main body after replacement of the ampoule easily causing a premature unintentional discharge of fluid.
- this could also result in an incorrect dosing which, in case of certain medication, could be extremely hazardous to the patient's health.
- the injection device comprises a bushing-shaped main body 1 which can be divided into a rear (distal) section 3 containing the tubular actuating device or discharge mechanism 7 and a front (proximal) section 2 containing a replaceable ampoule 4 and a piston 5 .
- a needle 6 with its distal end connected to the fluid to be administered can be screwed to the proximal end of the main body 1 .
- the actuating device 7 comprises a control button 8 , a threaded rod 9 with a flange 19 , a guide member 24 and a driving member 11 .
- the tubular driving member 11 is rigidly connected to the control button 8 to prevent twisting. At the proximal end, the driving member 11 surrounds two threaded flanges 27 , 27 ′ engaging in the thread of the threaded rod 9 .
- FIG. 18 shows that the threaded rod 9 comprises two level surfaces 12 , 12 ′ and apart from that is of a circular cross section, with the circular surfaces 13 , 13 ′ being threaded.
- the guide member 24 is rigidly connected to the distal section 3 of the main body 1 , thus preventing rotation or axial movement and is positioned in front of the driving member 11 .
- the aperture in the guide member 24 through which the threaded rod 9 passes (FIG. 19) is of the same cross section as the threaded rod 9 —although enlarged by certain tolerances.
- the threaded rod 9 can be shifted through the opening of the guide member in axial direction. A rotational movement of the threaded rod 9 is therefore not possible as the guide member 24 does not allow this.
- the control button 8 may be moved in axial direction or may be rotated. Where the control button is activated by being pushed in proximal direction, it will simultaneously shift the driving member 11 until its front face 14 pushes against the rear face 14 ′ of the guide member.
- the threaded rod 9 is connected to the driving member 11 by threaded flanges 27 , 27 ′ thus allowing any axial movement of the control button 8 to be transferred. See detailed description of threaded flanges 27 , 27 ′ below.
- the driving member 11 When turning the control button 8 to adjust an injection dose, the driving member 11 is also turned. This rotating movement can, however, not be transferred to the threaded rod 9 as the rod is rigidly seated in the guide member 24 . As a result of the rotating threaded flanges 27 , 27 ′ in driving member 11 , the threaded rod 9 is rigidly driven forward via the threaded sections of the circular surfaces 13 , 13 ′ (or backward, when reversing the rotation direction of the control button), thus bringing the flange 19 into the position required for the next injection dose to be discharged, i.e. the distance of the flange 19 from the piston 5 is respectively reduced.
- the actuating device 7 By pressing the control button 8 , the actuating device 7 is moved from its home position to the end position.
- the flange 19 pushes thereby against the piston 5 during this operation, carrying it along the set piston travel and thus discharging the pre-set volume of injection fluid through injection needle 6 .
- the travel of the flange 19 from the home position to the end position of the actuating device 7 always remains the same and corresponds to a constant distance by which the flange 19 is separated from the piston 5 before setting the injection dose. This process is described in detail in WO 93/16740.
- the threaded rod 9 When the fluid container 4 is empty and the threaded rod 9 is therefore in the extreme proximal position, the threaded rod must be returned to the extreme distal position.
- the injection device according to the invention allows the threaded rod 9 to be returned by activation of an unlocking slide 32 .
- FIGS. 17 and 18 show that both threaded flanges 27 , 27 ′ of the driving member 11 are designed as two half-shell threaded nut sections, each provided with two cams 28 , 28 ′, 29 , 29 ′.
- the unlocking slide 32 attached to the rear section 3 is connected to an internal spreader bushing 35 in the rear section 3 , with shifting of the unlocking slide 32 in distal direction causing the spreader bushing 35 to be shifted in distal direction.
- the spreader bushing 35 surrounds the driving member 11 and comprises four vertical tracks 30 , 30 ′, 31 , 31 ′ (FIG. 16), which extend towards the proximal end of the spreader bushing 35 outwardly at an angle.
- the tracks 30 , 30 ′, 31 , 31 ′ serve to accommodate the cams 28 , 28 ′, 29 , 29 ′ of the threaded flanges 27 , 27 ′.
- the spreader bushing 35 When the spreader bushing 35 is in the proximal position (FIG. 14), the threaded flanges 27 , 27 ′ surround the threaded rod 9 .
- the spreader bushing 35 is moved to its distal position (FIG.
- a notched surface 33 of the unlocking slide 32 arranged on the main body fits into a counter notched surface 34 on the proximal part of the spreader bushing 35 .
- the spreader bushing 35 is retained in its proximal position by the spring 16 .
- the user In order to release the threaded flange 27 , 27 ′ the user must actively shift the unlocking slide 32 into its distal position by simultaneous pushing it down. During this process, the notched surface 33 of the unlocking slide 32 engages in the counter notched surface 34 of the spreader bushing 35 , moving it backwards. Because of this movement, the cams 28 , 28 ′, 29 , 29 ′ must run over corresponding outwardly extending tracks 30 , 30 ′, 31 , 31 ′ of the spreader bushing 35 (FIGS. 16 - 18 ). This forced movement causes the threaded flanges 27 , 27 ′ to open (FIG.
- the threaded flanges 27 , 27 ′ can only be released from the threaded rod 9 with the actuating device 7 in its proximal position (FIG. 15).
- the tracks 30 , 30 ′, 31 , 31 ′ are of such a dimension that activation of the unlocking slide 32 in the operating position of the actuating device 7 (FIGS. 14 and 16) only causes the cams 28 , 28 ′, 29 , 29 ′ to slide in the vertical tracks 30 , 30 ′, 31 , 31 ′ without reaching their angled section at the proximal end of the spreader bushing 35 .
- the actuating device In order for the cams 28 , 28 ′, 29 , 29 ′ to reach the angled section of the tracks 30 , 30 ′, 31 , 31 ′ and to release themselves from the threaded rod 9 , the actuating device must also be in its proximal position (FIG. 15).
- the present invention provides an injection device and an actuator wherein the actuator comprises a first actuator component which is adapted to permit a second actuator component to be selectively moved when the first actuator component is manipulated by a third actuator component.
- the present invention provides an injection device and an actuator for the injection device wherein the actuator comprises a first actuator component comprising a counter component which is adapted to permit a second actuator component comprising a driven member to be selectively moved when the counter component is manipulated by a third actuator component.
- the present invention provides an injection device and an actuator for an injection device wherein the actuator comprises a first actuator component comprising a counter component which is adapted to permit a second actuator component comprising a driven member to be selectively moved when the counter component is manipulated by a third actuator component comprising a bushing which is selectively movable with and relative to the counter component.
- the present invention provides an actuator for an injection device, wherein the actuator comprises a generally rod-shaped driven member having a structured surface portion, a counter component having a structured surface portion engaging with the structured surface portion of the driven member, whereby the driven member is movable by the counter component, and a spreader bushing for spreading open the counter component by a movement relative to the counter component, thereby allowing the driven member to shift freely, wherein the spreader bushing is selectively movable with and relative to the counter component.
- a driven member can be shifted freely in an axial direction by forcibly opening the counter component upon actuation of a single element.
- FIG. 1 shows a first embodiment of an injection device according to the invention with the threaded rod in a distal position and a blocked unlocking slide;
- FIG. 2 shows a first embodiment of an injection device according to the invention with a pushed control button and a blocked unlocking slide;
- FIG. 3 shows a first embodiment of an injection device according to the invention with a released threaded rod and a pushed unlocking slide, the control button not being pushed;
- FIG. 4 shows a cross sectional view along line A-A of FIG. 1;
- FIG. 5 shows a perspective view of a spreader bushing surrounding a threaded flange according to the invention
- FIG. 6 shows a second embodiment of an injection device according to the invention with the container not being inserted
- FIG. 7 shows the injection device of FIG. 6 with the inserted container
- FIG. 8 shows the injection device of FIG. 7 with the control button being pushed
- FIG. 9 shows the injection device of FIG. 7 with the threaded rod being released
- FIG. 10 shows the injection device of FIG. 7 in a cross-sectional view perpendicular to the view of FIG. 7;
- FIG. 11 shows a cross sectional view along line B-B of FIG. 9;
- FIG. 12 shows a cross sectional view along line A-A of FIG. 8;
- FIG. 13 shows a cross sectional view along line C-C of FIG. 9;
- FIG. 14 shows an injection device of the prior art with a retained threaded rod
- FIG. 15 shows an injection device of the prior art with a free threaded rod
- FIG. 16 shows an injection device of the prior art in which the actuating device has been removed
- FIG. 17 shows a cross section along line A-A of FIG. 14;
- FIG. 18 shows a cross section along line B-B of FIG. 15.
- FIG. 19 shows a cross section along line C-C of FIG. 15.
- the actuating device 7 comprises a control button 8 , a threaded rod 9 with a flange 19 , a guide member 24 and a driving member 11 .
- the tubular driving member 11 is rigidly connected to the control button 8 .
- the control button 8 When the control button 8 is actuated, for example rotated or pushed, the corresponding movement is transferred to the driving member 11 , the spreader bushing 37 and the threaded flanges 27 , 27 ′.
- the threaded flanges 27 , 27 ′ engage with the threaded rod 9 during normal operation.
- the spreader bushing 37 surrounds both the driving member 11 and the threaded flanges 27 , 27 ′ and moves with them during normal operation.
- the driving member 11 When turning the control button 8 to adjust an injection dose, the driving member 11 is also turned. This rotating movement can, however, not directly be transferred to the threaded rod 9 as the rod 9 is rigidly seated in the guide member 24 .
- projections of the driving member 11 (not shown) or of any other suitable element to transfer a movement of the driving member engage with recesses 37 a , 37 b of the spreader bushing 37 to rotate the spreader bushing 37 when the driving member 11 is turned.
- Projections 37 c , 37 d of the spreader bushing 37 engage with projections 27 a or 27 b of a first flange 27 shown in FIG.
- the spreader bushing 37 is also moved in the proximal direction when pressing control button 8 to remain basically in the same relative position to the flanges 27 , 27 ′.
- the threaded rod 9 When the fluid container 4 is empty and the threaded rod 9 is therefore in an extreme proximal position, the threaded rod must be returned to an extreme distal position.
- the injection device according to the invention allows the threaded rod 9 to be returned only by activation of the unlocking slide 32 , as shown in FIG. 3.
- the blocking element 36 a is moved to a proximal position, thereby allowing the unlocking slide 32 to be moved in a direction to engage with a recess 37 e of the spreader bushing 37 , which either directly causes a movement of the spreader bushing in the distal direction, relative to the flanges 27 , 27 ′, thus spreading flanges 27 , 27 ′ open.
- This movement can be effected by the provision of tilted surfaces effecting an axial movement of spreader bushing 37 when moving unlocking slide 32 in radial direction. It is also possible to effect this movement by simply engaging unlocking slide 32 with spreader bushing 37 and subsequent axial movement of slide 32 .
- spreader bushing 37 Since the spreader bushing 37 is moved together with the flanges 27 , 27 ′ during normal operation, spreader bushing 37 can always be in a position close to the flanges 27 , 27 ′ so that only a short relative movement of the spreader bushing 37 is required to spread flanges 27 , 27 ′ open. Thus, control button 8 does not have to be pressed to unlock rod 9 .
- FIGS. 4 and 5 show that both threaded flanges 27 , 27 ′ are designed as two half-shelf threaded nut sections which surround the rod 9 having circular surfaces 13 , 13 ′ being threaded which engage with the threaded surface 27 c on the inner side of flanges 27 , 27 ′.
- the outer diameter of the threaded flanges 27 , 27 ′ becomes smaller in distal direction.
- Projections 27 a , 27 b , 27 ′ a , 27 ′ b of the flanges 27 , 27 ′ are positioned to form grooves G between the respective projections 27 a and 27 ′ a or 27 b and 27 ′ b which become smaller in the distal direction.
- Projections 37 c , 37 d of the spreader bushing 37 form a wedge-shaped part 37 g having a width gradually decreasing in the distal direction, so that if the spreader bushing 37 is moved relative to the flanges 27 , 27 ′, the flanges 27 , 27 ′ are guided by grooves 37 h , 37 i adjacent the wedge-shaped part 37 g to thereby open or close the flanges 27 , 27 ′.
- Recesses can be provided at a variety of positions along bushing 37 , so that more than the shown recesses 37 e and 37 f can be provided.
- the recesses can either be formed around bushing 37 or only at district portions, as shown in FIG. 5.
- Notches can be provided to allow rotations of bushing 37 only with a predefined angle in the end position.
- FIGS. 6 to 13 A second embodiment of the invention is described with reference to FIGS. 6 to 13 .
- FIG. 6 shows an injection device according to a second embodiment of the invention.
- the container 4 is not inserted.
- spreader bushing 37 has two recesses 37 e , 37 f surrounding the spreader bushing 37 .
- Unlocking slide 32 can engage with spreader bushing 37 using either of the recesses 37 e , 37 f so that spreader bushing 37 can be moved relative to the flanges 27 , 27 ′ in two positions of the injection device, namely with control button 8 being in the normal position, as shown in FIG.
- the flanges 27 , 27 ′ can be spread open starting from two positions of the injection device, namely with control button 8 being in the normal position, or control button 8 being pressed.
- only one element, namely unlocking slide 32 has to be actuated by the user to unlock rod 9 to allow it to be moved to the distal position, when the injection device is held with the distal end facing downwards.
- the engaging portion of unlocking slide 32 can be tilted with respect to the axial direction of the injection device to cause an immediate movement of spreader bushing 37 , when unlocking slide 32 is pressed down, as shown schematically in FIG. 3 of the first embodiment.
- it is also possible to provide the possibility for engagement of unlocking slide 32 with spreader bushing 37 so that the user first has to perform an engaging operation, for example by pressing down unlocking slide 32 of FIG. 6, and then has to perform a shifting operation by moving unlocking slide 32 coupled with spreader bushing 37 in the distal direction, thus effecting a movement of spreader bushing 37 in the distal direction relative to flanges 27 , 27 ′, thus spreading flanges 27 , 27 ′ open.
- it is also possible to provide a mechanism which will open the flanges 27 , 27 ′ by any other movement of unlocking slide 32 e.g. in the proximal direction.
- control button 8 is turned to adjust a dose to be injected, as described above, and is then pressed to move rod 9 in a proximal direction, thereby injecting the preset dose.
- Spreader bushing 37 is moved together with driving member 11 during normal operation and remains thus in a basical fixed relative relationship.
- unlocking slide 32 can be released, thus effecting that spring 38 pushes spreader bushing 37 back to its normal position, thereby again engaging the threaded flanges 27 , 27 ′ with the threaded surfaces 13 , 13 ′ of rod 9 .
- FIG. 10 again shows the basic concept of the inventive injection device with a cross-sectional view in a plane turned by 90° with respect to the cross-sectional views described above.
- FIG. 11 shows a cross-sectional view along line B-B of FIG. 9.
- Flanges 27 , 27 ′ are spread open by the wedge-shaped elements 37 g of spreader bushing 37 , which engage with the projection 27 a , 27 b of flange 27 which are shown and described with reference to FIG. 5, and the corresponding projections of flange 27 ′.
- FIG. 12 shows the flanges 27 , 27 ′ in a closed condition being engaged with rod 9 , seen in the cross-sectional view along line A-A in FIG. 8.
- spreader bushing 37 is in a more proximal position relative to the flanges 27 , 27 ′, as compared to the state shown in FIG. 11.
- FIG. 13 is a cross-sectional view along line C-C in FIG. 9 and shows the coaxial arrangement of the inventive injection device.
Abstract
Description
- The present invention relates to an injection device for injecting fluid from a fluid container. It also relates to an actuator for such an injection device.
- Syringe-shaped injection devices for injecting fluids have been known for some time. They contain a bushing-shaped main body which can be screwed together at approximately the centre and can be divided into two main sections:
- a distal section (facing away from the patient) containing the discharge mechanism and comprising at least one rod-shaped driven member having a structured surface (e.g. a screw rod), a hollow cylindrical counter component corresponding to the driven member, provided with a structured internal sleeve (e.g. a screw nut); and
- a control button; and
- a proximal section (facing the patient) containing the fluid to be administered and a movable piston.
- At the proximal end of the main body, a needle and a needle holder are attached, allowing the fluid to be discharged from the device; known needles of this type are for instance needles as described in WO95/01812.
- The connecting member between the proximal and the distal section of the main body is the driven member, shifting the piston by the required dose in proximal direction and discharging the fluid through the needle.
- Often the fluid to be injected is not directly contained in the main body but in an ampoule or container, with the fluid being stored between a piercable membrane and a piston displaceable by sliding.
- Depending on the injection device, various features are expected from the discharge mechanism. There are devices allowing only a single discharge, devices allowing several discharges of the same dose and devices allowing freely selectable discharges.
- For patients using injection devices allowing a change of ampoules, it is—irrespective of the complexity of the discharge mechanism—extremely difficult to wind back the driven member to the initial position in order to make the device ready for operation after the ampoule has been changed. Devices requiring the driven member to be rewound by the control button are known from WO93/16740. Devices allowing the threaded rod to be pushed back, as in publications U.S. Pat. No. 4,592,745 and EP-A-0 554 995, are more easily operated by patients. According to these prior art devices the threaded nut is spread due to the release of the distal section from the proximal section of the main body, allowing the threaded rod to move freely without any conscious operation by the patient, with screwing together of both sections of the main body after replacement of the ampoule easily causing a premature unintentional discharge of fluid. Depending on the injection device, this could also result in an incorrect dosing which, in case of certain medication, could be extremely hazardous to the patient's health.
- An injection device to remedy this situation is known from applicants patent U.S. Pat. No. 6,090,080, the disclosure thereof is incorporated herein by reference. Such a known injection device is described with reference to FIGS.14 to 19.
- In the subsequent description, the terms proximal and distal are used in their usual medical sense, i.e. proximal=facing the patient and distal=facing away from the patient.
- As shown in FIG. 14, the injection device comprises a bushing-shaped main body1 which can be divided into a rear (distal)
section 3 containing the tubular actuating device ordischarge mechanism 7 and a front (proximal)section 2 containing areplaceable ampoule 4 and apiston 5. Aneedle 6 with its distal end connected to the fluid to be administered can be screwed to the proximal end of the main body 1. The actuatingdevice 7 comprises acontrol button 8, a threadedrod 9 with aflange 19, aguide member 24 and adriving member 11. - The
tubular driving member 11 is rigidly connected to thecontrol button 8 to prevent twisting. At the proximal end, thedriving member 11 surrounds two threadedflanges rod 9. - FIG. 18 shows that the threaded
rod 9 comprises twolevel surfaces circular surfaces - The
guide member 24 is rigidly connected to thedistal section 3 of the main body 1, thus preventing rotation or axial movement and is positioned in front of thedriving member 11. The aperture in theguide member 24, through which the threadedrod 9 passes (FIG. 19) is of the same cross section as the threadedrod 9—although enlarged by certain tolerances. As theguide member 24, in contrast to the drivingmember 11, is not threaded, the threadedrod 9 can be shifted through the opening of the guide member in axial direction. A rotational movement of the threadedrod 9 is therefore not possible as theguide member 24 does not allow this. - The
control button 8 may be moved in axial direction or may be rotated. Where the control button is activated by being pushed in proximal direction, it will simultaneously shift thedriving member 11 until itsfront face 14 pushes against therear face 14′ of the guide member. - The threaded
rod 9 is connected to the drivingmember 11 by threadedflanges control button 8 to be transferred. See detailed description of threadedflanges - The axial movement is effected against the bias of a
spring 16, returning the actuatingdevice 7 to its home position (FIG. 14). - When turning the
control button 8 to adjust an injection dose, thedriving member 11 is also turned. This rotating movement can, however, not be transferred to the threadedrod 9 as the rod is rigidly seated in theguide member 24. As a result of the rotating threadedflanges member 11, the threadedrod 9 is rigidly driven forward via the threaded sections of thecircular surfaces flange 19 into the position required for the next injection dose to be discharged, i.e. the distance of theflange 19 from thepiston 5 is respectively reduced. - By pressing the
control button 8, the actuatingdevice 7 is moved from its home position to the end position. Theflange 19 pushes thereby against thepiston 5 during this operation, carrying it along the set piston travel and thus discharging the pre-set volume of injection fluid throughinjection needle 6. The travel of theflange 19 from the home position to the end position of the actuatingdevice 7 always remains the same and corresponds to a constant distance by which theflange 19 is separated from thepiston 5 before setting the injection dose. This process is described in detail in WO 93/16740. - When the
fluid container 4 is empty and the threadedrod 9 is therefore in the extreme proximal position, the threaded rod must be returned to the extreme distal position. The injection device according to the invention allows the threadedrod 9 to be returned by activation of anunlocking slide 32. - FIGS. 17 and 18 show that both threaded
flanges member 11 are designed as two half-shell threaded nut sections, each provided with twocams - The
unlocking slide 32 attached to therear section 3 is connected to an internal spreader bushing 35 in therear section 3, with shifting of theunlocking slide 32 in distal direction causing the spreader bushing 35 to be shifted in distal direction. - The spreader bushing35 surrounds the
driving member 11 and comprises fourvertical tracks tracks cams flanges flanges rod 9. When the spreader bushing 35 is moved to its distal position (FIG. 15) with theunlocking slide 32, the threadedflanges cams tracks rod 9 can be freely shifted in axial direction. - A
notched surface 33 of the unlockingslide 32 arranged on the main body fits into a counter notchedsurface 34 on the proximal part of the spreader bushing 35. - In principle, the
spreader bushing 35 is retained in its proximal position by thespring 16. In order to release the threadedflange unlocking slide 32 into its distal position by simultaneous pushing it down. During this process, thenotched surface 33 of theunlocking slide 32 engages in the counter notchedsurface 34 of the spreader bushing 35, moving it backwards. Because of this movement, thecams tracks flanges rod 9. When at the same time the injection device is held with thedosing button 8 down, gravity causes the threadedrod 9 to automatically fall back into its distal position. Upon releasing theunlocking slide 32, the spreader bushing 35 slides forward again. At the same time thecams tracks flange unlocking slide 32 is moved into the proximal position by means that are not shown. - For safety reasons, the threaded
flanges rod 9 with theactuating device 7 in its proximal position (FIG. 15). For this reason thetracks unlocking slide 32 in the operating position of the actuating device 7 (FIGS. 14 and 16) only causes thecams vertical tracks cams tracks rod 9, the actuating device must also be in its proximal position (FIG. 15). - To release the threaded
rod 9 thecontrol button 8 has to be pressed, as shown in FIG. 15, so that theflanges vertical tracks 30′, 31′ to the point where thetracks 30′, 31′ spread outwards. Then, after actuating the unlockingslide 32, thespreader bushing 35 which is during normal operation in a fixed and stationary relationship, is moved in the distal direction, thereby spreading theflanges rod 9. Thus, two elements have to be actuated by the user at the same time to slide back therod 9, namely thecontrol button 8 and the unlockingslide 32. - In one embodiment, the present invention provides an injection device and an actuator wherein the actuator comprises a first actuator component which is adapted to permit a second actuator component to be selectively moved when the first actuator component is manipulated by a third actuator component.
- In one embodiment, the present invention provides an injection device and an actuator for the injection device wherein the actuator comprises a first actuator component comprising a counter component which is adapted to permit a second actuator component comprising a driven member to be selectively moved when the counter component is manipulated by a third actuator component.
- In one embodiment, the present invention provides an injection device and an actuator for an injection device wherein the actuator comprises a first actuator component comprising a counter component which is adapted to permit a second actuator component comprising a driven member to be selectively moved when the counter component is manipulated by a third actuator component comprising a bushing which is selectively movable with and relative to the counter component.
- In one embodiment, the present invention provides an actuator for an injection device, wherein the actuator comprises a generally rod-shaped driven member having a structured surface portion, a counter component having a structured surface portion engaging with the structured surface portion of the driven member, whereby the driven member is movable by the counter component, and a spreader bushing for spreading open the counter component by a movement relative to the counter component, thereby allowing the driven member to shift freely, wherein the spreader bushing is selectively movable with and relative to the counter component.
- According to the present invention, a driven member can be shifted freely in an axial direction by forcibly opening the counter component upon actuation of a single element.
- The invention is described with reference to the enclosed drawings showing embodiments of the invention, where:
- FIG. 1 shows a first embodiment of an injection device according to the invention with the threaded rod in a distal position and a blocked unlocking slide;
- FIG. 2 shows a first embodiment of an injection device according to the invention with a pushed control button and a blocked unlocking slide;
- FIG. 3 shows a first embodiment of an injection device according to the invention with a released threaded rod and a pushed unlocking slide, the control button not being pushed;
- FIG. 4 shows a cross sectional view along line A-A of FIG. 1;
- FIG. 5 shows a perspective view of a spreader bushing surrounding a threaded flange according to the invention;
- FIG. 6 shows a second embodiment of an injection device according to the invention with the container not being inserted;
- FIG. 7 shows the injection device of FIG. 6 with the inserted container;
- FIG. 8 shows the injection device of FIG. 7 with the control button being pushed;
- FIG. 9 shows the injection device of FIG. 7 with the threaded rod being released;
- FIG. 10 shows the injection device of FIG. 7 in a cross-sectional view perpendicular to the view of FIG. 7;
- FIG. 11 shows a cross sectional view along line B-B of FIG. 9;
- FIG. 12 shows a cross sectional view along line A-A of FIG. 8;
- FIG. 13 shows a cross sectional view along line C-C of FIG. 9;
- FIG. 14 shows an injection device of the prior art with a retained threaded rod;
- FIG. 15 shows an injection device of the prior art with a free threaded rod;
- FIG. 16 shows an injection device of the prior art in which the actuating device has been removed;
- FIG. 17 shows a cross section along line A-A of FIG. 14;
- FIG. 18 shows a cross section along line B-B of FIG. 15; and
- FIG. 19 shows a cross section along line C-C of FIG. 15.
- Reference is made to the above description of FIGS.14 to 19 for the general function of the inventive injection device, except the function of the unlocking
slide 32,spreader bushing 37 andflanges - Referring to FIG. 1, the
actuating device 7 comprises acontrol button 8, a threadedrod 9 with aflange 19, aguide member 24 and a drivingmember 11. - The
tubular driving member 11 is rigidly connected to thecontrol button 8. When thecontrol button 8 is actuated, for example rotated or pushed, the corresponding movement is transferred to the drivingmember 11, thespreader bushing 37 and the threadedflanges flanges rod 9 during normal operation. Thespreader bushing 37 surrounds both the drivingmember 11 and the threadedflanges - When turning the
control button 8 to adjust an injection dose, the drivingmember 11 is also turned. This rotating movement can, however, not directly be transferred to the threadedrod 9 as therod 9 is rigidly seated in theguide member 24. Referring to FIG. 5, projections of the driving member 11 (not shown) or of any other suitable element to transfer a movement of the driving member engage withrecesses 37 a, 37 b of thespreader bushing 37 to rotate thespreader bushing 37 when the drivingmember 11 is turned.Projections spreader bushing 37 engage withprojections 27 a or 27 b of afirst flange 27 shown in FIG. 5 and asecond flange 27′ (not shown) to transfer the rotational movement ofspreader bushing 37 to theflanges flanges rod 9 seated in theguide member 24 preventing rotational movement of therod 9, as described above, is driven forward via the threaded sections on rod 9 (or backward, when reversing the rotation direction of the control button 8), thus bringing theflange 19 into the position required for the next injection dose to be discharged, i.e. the distance of theflange 19 from thepiston 5 is respectively increased or reduced. - When pressing the
control button 8 against the force ofspring 16, as shown in FIG. 2, the actuating device is moved in the proximal direction.Flange 19 pushes thereby againstpiston 5 during this operation, carrying it along the set piston travel and thus discharging the pre-set volume of injection fluid throughinjection needle 6. - According to the invention the
spreader bushing 37 is also moved in the proximal direction when pressingcontrol button 8 to remain basically in the same relative position to theflanges - The axial movement is effected against the bias of a
spring 16, returning theactuating device 7 to its home position after injection, as shown in FIG. 1. - When the
fluid container 4 is empty and the threadedrod 9 is therefore in an extreme proximal position, the threaded rod must be returned to an extreme distal position. The injection device according to the invention allows the threadedrod 9 to be returned only by activation of the unlockingslide 32, as shown in FIG. 3. - When the
fluid container 4 is removed from the injection device, as shown in FIG. 3, the blocking element 36 a is moved to a proximal position, thereby allowing the unlockingslide 32 to be moved in a direction to engage with arecess 37 e of thespreader bushing 37, which either directly causes a movement of the spreader bushing in the distal direction, relative to theflanges flanges spreader bushing 37 when moving unlockingslide 32 in radial direction. It is also possible to effect this movement by simply engaging unlockingslide 32 withspreader bushing 37 and subsequent axial movement ofslide 32. Since thespreader bushing 37 is moved together with theflanges spreader bushing 37 can always be in a position close to theflanges spreader bushing 37 is required to spreadflanges control button 8 does not have to be pressed to unlockrod 9. - FIGS. 4 and 5 show that both threaded
flanges rod 9 havingcircular surfaces surface 27 c on the inner side offlanges flanges -
Projections flanges respective projections Projections spreader bushing 37 form a wedge-shapedpart 37 g having a width gradually decreasing in the distal direction, so that if thespreader bushing 37 is moved relative to theflanges flanges grooves 37 h, 37 i adjacent the wedge-shapedpart 37 g to thereby open or close theflanges - Recesses can be provided at a variety of positions along
bushing 37, so that more than the shown recesses 37 e and 37 f can be provided. The recesses can either be formed aroundbushing 37 or only at district portions, as shown in FIG. 5. Notches can be provided to allow rotations ofbushing 37 only with a predefined angle in the end position. - A second embodiment of the invention is described with reference to FIGS.6 to 13.
- FIG. 6 shows an injection device according to a second embodiment of the invention. The
container 4 is not inserted. According to the secondembodiment spreader bushing 37 has tworecesses spreader bushing 37. Unlockingslide 32 can engage withspreader bushing 37 using either of therecesses spreader bushing 37 can be moved relative to theflanges control button 8 being in the normal position, as shown in FIG. 6, so that unlockingslide 32 engages with theproximal recess 37 e ofspreader bushing 37, or withcontrol button 8 being pressed, so that unlockingslide 32 engages with thedistal recess 37 f ofspreader bushing 37, as shown in FIGS. 8 and 9. Thus, according to the second embodiment, theflanges control button 8 being in the normal position, orcontrol button 8 being pressed. According to the invention only one element, namely unlockingslide 32, has to be actuated by the user to unlockrod 9 to allow it to be moved to the distal position, when the injection device is held with the distal end facing downwards. - In general it is possible according to the invention that more than only two
recesses spreader bushing 37. Any other element or structure can be used for the invention which allows an engagement of unlockingslide 32 withspreader bushing 37, as for example a structured or notched surface of the unlockingslide 32, which can engage with the respective counter element onspreader bushing 37. - The engaging portion of unlocking
slide 32 can be tilted with respect to the axial direction of the injection device to cause an immediate movement ofspreader bushing 37, when unlockingslide 32 is pressed down, as shown schematically in FIG. 3 of the first embodiment. However, it is also possible to provide the possibility for engagement of unlockingslide 32 withspreader bushing 37, so that the user first has to perform an engaging operation, for example by pressing down unlockingslide 32 of FIG. 6, and then has to perform a shifting operation by moving unlockingslide 32 coupled withspreader bushing 37 in the distal direction, thus effecting a movement ofspreader bushing 37 in the distal direction relative toflanges flanges flanges slide 32, e.g. in the proximal direction. - After inserting the
container 4, as shown in FIG. 7,control button 8 is turned to adjust a dose to be injected, as described above, and is then pressed to moverod 9 in a proximal direction, thereby injecting the preset dose.Spreader bushing 37 is moved together with drivingmember 11 during normal operation and remains thus in a basical fixed relative relationship. - When the
rod 9 is in a proximal position after performing one or more injection operations,container 4 is removed as shown in FIG. 8 and unlockingslide 32 is pressed to engage with thedistal recess 37 f ofspreader bushing 37 as shown in FIG. 9. After thisengagement unlocking slide 32 is moved in the distal direction of the injection device, thus movingspreader bushing 37 in the distal direction, which biases spring 38 located between drivingmember 11 andspreader bushing 37. This movement ofspreader bushing 37 in axial direction causes a movement of theflanges flanges Rod 9 is now movable inside the injection device and can be brought to the distal position by simply holding the injection device with the distal side facing downwards, causingrod 9 to fall into an extreme distal position. - After
rod 9 is brought into its distalposition unlocking slide 32 can be released, thus effecting thatspring 38 pushes spreader bushing 37 back to its normal position, thereby again engaging the threadedflanges rod 9. - FIG. 10 again shows the basic concept of the inventive injection device with a cross-sectional view in a plane turned by 90° with respect to the cross-sectional views described above.
- FIG. 11 shows a cross-sectional view along line B-B of FIG. 9.
Flanges elements 37 g ofspreader bushing 37, which engage with theprojection 27 a, 27 b offlange 27 which are shown and described with reference to FIG. 5, and the corresponding projections offlange 27′. - FIG. 12 shows the
flanges rod 9, seen in the cross-sectional view along line A-A in FIG. 8. In thisstate spreader bushing 37 is in a more proximal position relative to theflanges - FIG. 13 is a cross-sectional view along line C-C in FIG. 9 and shows the coaxial arrangement of the inventive injection device.
- In general, it is not intended that the invention described herein be restricted to the described embodiments. Reference should be made to the appended claims to ascertain the spirit and scope of the invention.
Claims (19)
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US09/784,661 US6673049B2 (en) | 2001-02-15 | 2001-02-15 | Injection device for injecting fluid |
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US09/784,661 US6673049B2 (en) | 2001-02-15 | 2001-02-15 | Injection device for injecting fluid |
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US20020111587A1 true US20020111587A1 (en) | 2002-08-15 |
US6673049B2 US6673049B2 (en) | 2004-01-06 |
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